Sleep Treatment for Teens (RCT Phase)
Purpose
The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
Conditions
- Sleep Problems
- Suicidal Ideation
- Suicidal Behavior
Eligibility
- Eligible Ages
- Between 14 Years and 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion:
1. Age 14-18 years old.
2. Recent hospitalization due to suicide risk (i.e., suicide attempts,
aborted/interrupted attempts, or suicide ideation with intent and/or a plan) using
an abbreviated version of the semi-structured and well-validated Columbia Suicide
Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents
will need to complete the baseline within three months (Study 1) or 45 days (Study
2) of discharge in order to capture the high-risk post-discharge period, which is up
to 3 months following discharge from acute psychiatric hospitalization (Chung et
al., 2017).
3. Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a
sample with clinically significant insomnia symptoms. The ISI will also be
administered to gain additional information about the nature of adolescents' sleep
problems in order to confirm primary insomnia. ISI scores may also be obtained via
chart review when applicable
4. Access to or willingness to use a compatible Smart Device. SleepioTM works with any
internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later
or on any Android device running Android OS 8.0 or later. Metricwire is compatible
with all devices that SleepioTM is compatible with. If an interested adolescent does
not have access to their own smart device, the research team will offer them a
loaner device for the duration of the treatment/follow-up phase.
Adolescents will be excluded based on the following exclusion criteria:
1. Prior CBT-I treatment, which would indicate lack of response to a prior reasonable
dose of this treatment.
2. Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction)
may be risky for this population.
3. Substance use disorder that is primary to insomnia which would require alternative
treatment.
4. Presence of factors that may reduce participants' ability to consent or complete the
study procedures (e.g., current psychosis, other-directed violence; severe cognitive
impairment, non-English speaking).
5. Unwillingness to wear wrist actigraphy or complete the EMA surveys.
6. Not having a parent willing to provide permission (if participant is a minor) or to
consent to their own participation (required for all adolescents). Eligibility will
not be based on biological sex, gender identity, race, or ethnicity. These variables
will be assessed during screening to compare those who are and are not eligible.
7. Having a sibling who has enrolled in the study.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Treatment as usual (TAU) + ecological momentary assessment (EMA) |
Treatment as usual plus assessments via EMA |
|
|
Experimental Sleepio (TM) + Treatment as usual (TAU) + EMA |
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. |
|
Recruiting Locations
Piscataway, New Jersey 08854
Norfolk, Virginia 23507
More Details
- Status
- Recruiting
- Sponsor
- Rutgers, The State University of New Jersey